- Provide technical / scientific support for internal and external technology transfer of manufacturing processes. Implement process validation activities and post-transfer support. Trouble shoot problems encountered during tech transfer / process optimization / commercial manufacture and supports continuous improvement.
RESPONSIBILITIES:
Planning and project support
- Research and report on solutions to improve tracking, planning and collaboration
- New product introduction assessment
- Technical evaluation of products and processes
- Draft transfer protocols, project plans and timelines and prepare proposals and status reports
- Compile technical documents that comply with local and international regulatory guidelines
- Support technology transfer team activities and projects
- Identify project issues and recommend methods for resolution
Project management
- Manage aspects of tech transfer projects, including:
- Feasibility and risk assessment
- Planning
- Trial and validation batch manufacturing
- Execution and tracking
Manufacturing science, technology troubleshooting
- Provide planned and unplanned production support
- Troubleshoot process / product problems
- Guide during process changes, process optimization including API/IPI source changes
- Provide manufacturing science & technical support for deviations, CAPA”s, OOS’s and technical complaints
Risk management and process validation
- Conduct feasibility and risk assessments
- Ensure that project planning encompasses quality, risk and process validation aspects
- Ensure regulatory compliance throughout tech transfer processes
- Support investigations associated with tech transfer activities
- Carry out Process Qualification (PQ) and Continued Process Verification (CPV) activities to validate transferred processes
Background/experience
- 4 to 6 years’ experience in technical transfer , with two years in a pharmaceutical manufacturing environment, or one to two years’ experience in relevant manufacturing environment
- Bachelor’s degree in Pharmacy, Engineering or similar
Specific job skills
- Knowledge of Pharmaceutical technical issues, manufacturing processes and operations environment
- Knowledge of validation, regulatory affairs, R&D, and new product transfer
- Knowledge of local and international pharma guidelines
Competencies
- Offering Insights
- Investigating Possibilities
- Innovative Thinking
- Technical / scientific report writing
- Data analysis
Aspen is committed to the principles of equal employment opportunity and suitably qualified job applicants are invited to submit their CVs online on or before the specified date. Preference will be given to applicants from designated groups, through a fair recruitment and selection process, in accordance with laws governing employment equity, where such laws are applicable to the Aspen entity that will employ the successful candidate.
Only short-listed candidates will be contacted, thus if you have not heard from the HR department within 30 days of this advert closing, please consider your application unsuccessful.
Internal Applicants must inform their direct line managers of their application. Applications must be completed using an Aspen email address.